Promoting Positive Outcomes for Individuals With ASD: Linking Early Detection, Treatment, and Long-term Outcomes

NCT03333629 | Completed Phase 4

• 1 other identifier: R01MH115715
• Study Type: interventional
• Target: 2,087
• Locations: 1 country
• Sites: 3

Brief Summary

Autism spectrum disorder (ASD) is defined by impaired social engagement and social communication, and repetitive, restricted, or stereotyped behaviors and interests. The average age of diagnosis in the US is after the fourth birthday. However, children who start ASD-specific early intervention have better outcomes than children start later. The current study will address a gap identified by the US Prevention Services Task Force, namely that children detected through screening respond positively to early intervention. This study will directly relate early detection strategies to early intervention, and measure the impact of age of intervention onset on outcomes when children are entering kindergarten. Local pediatric providers will be randomized to provide either usual care, or to an experimental condition in which autism early detection strategies are enhanced through the addition of specific procedures. Across all sites, 8,000 children will be recruited through their participating pediatric practice. Qualifying children will receive up to one year of early intensive behavioral intervention, after getting an ASD diagnosis. Primary outcome measures will include children's cognitive functioning and ASD symptom severity, which will be measured at multiple time points. The investigators predict that this study will inform early detection strategies which will result in improving children's social and cognitive functioning, mitigating lifespan disability, reducing societal costs, and improving personal well-being and productivity of individuals with ASD.

Conditions

Autism Spectrum Disorder

Keywords

Autistic Disorder; Early Detection; Early Intervention

Outcome Measures

Primary Outcomes (2)

• Change in ASD Symptom Severity

  ASD symptom severity will be measured with the Brief Observation of Social Communication Change (BOSCC)

  Change from pre-treatment to immediately post-treatment; 10 minutes

• Change in Cognitive Functioning

  Cognitive functioning will be measured by the Mullen Scales of Early Learning (MSEL).

  Change from pre-treatment to immediately post-treatment; 60 minutes

Secondary Outcomes (9)

• Adaptive Functioning

  Immediately post-treatment, 48 m, 60 m; 45 minutes

• ASD Symptoms - secondary measure1

  48 m, 60 m; 45 minutes

• Kindergarten Readiness

  60 m; 45 minutes

• Social Engagement

  Immediately post-treatment, 48 m, 60 m; 15 minutes

• Long-term change in Cognitive Functioning

  48 m, 60 m; 60 minutes

Study Arms (2)

Enhanced early detection

EXPERIMENTAL

Providers will receive training to administer enhanced early detection strategies.

Behavioral: Enhanced early detection

Usual care

NO INTERVENTION

Providers will not change their early detection strategies, but will be monitored.

Interventions

Enhanced early detection BEHAVIORAL

standardized screening

Enhanced early detection

Eligibility Criteria

• Age: 16 Months - 58 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• child attended 18 m visiting at participating pediatric practice
• legal guardian is fluent in English or Spanish

You may not qualify if:

• child has severe sensory or motor deficit that precludes completing standardized evaluation

Sponsors & Collaborators

• Drexel University: lead
• University of California, Davis: collaborator
• University of Connecticut: collaborator

Study Sites (3)

University of California, Davis

Sacramento, California, 95817, United States

Location

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Vivanti G, Algur Y, Ryan V, McClure LA, Fein D, Stahmer AC, Wieckowski AT, Robins DL. The Impact of Using Standardized Autism Screening on Referral to Specialist Evaluation for Young Children on the Autism Spectrum: A Cluster-Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2025 Jun;64(6):686-698. doi: 10.1016/j.jaac.2024.08.502. Epub 2024 Oct 15.

  PMID: 39454668 DERIVED

• McClure LA, Lee NL, Sand K, Vivanti G, Fein D, Stahmer A, Robins DL. Connecting the Dots: a cluster-randomized clinical trial integrating standardized autism spectrum disorders screening, high-quality treatment, and long-term outcomes. Trials. 2021 May 2;22(1):319. doi: 10.1186/s13063-021-05286-6.

  PMID: 33934719 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Diana Robins, PhD

  Drexel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: November 7, 2017
• Study Start: November 29, 2017
• Primary Completion: September 6, 2023
• Study Completion: June 30, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: semi-annual uploads beginning December 2018
• Access Criteria: as per NDAR requirements

Locations

US (3)